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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-400-10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Visual Disturbances (2140)
Event Date 02/12/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a pipeline device procedure was possibly related to patient developing migraines with aura (headache with visual symptoms of flashing lights on day 1 of index procedure leading to extended stay in hospital. The issue is resolved. The patient was being treated for a saccular aneurysm in the c6 segment of the right internal carotid artery. The maximum diameter is 5. 7mm and the dome height is 3. 2mm.  event related to ancillary device.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12355989
MDR Text Key267746626
Report Number2029214-2021-01049
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-10
Device Catalogue NumberPED2-400-10
Device Lot NumberA874062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/31/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/23/2021 Patient Sequence Number: 1
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